Nucleosides

Aprea Therapeutics Announces Positive Results from Phase 2 Trial of Eprenetapopt + Azacitidine for Post-Transplant Maintenance Therapy in TP53 Mutant MDS and AML

Retrieved on: 
Wednesday, July 21, 2021
Chemical compounds, Organic compounds, Heterocyclic compounds, Orphan drugs, Lactams, Nucleosides, Triazines, Antineoplastic drugs, Azacitidine, Venetoclax, H. Lee Moffitt Cancer Center & Research Institute, 7+3

In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial.

Key Points: 
  • In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial.
  • The post-transplant RFS and OS data with eprenetapopt and azacitidine maintenance therapy in these very difficult-to-treat TP53 mutant MDS and AML patients are incredibly exciting, said trial principal investigator Asmita Mishra, M.D., of the H. Lee Moffitt Cancer Center and Research Institute.
  • Post-transplant maintenance therapy with eprenetapopt and azacitidine could, if approved, represent a new treatment paradigm that meaningfully improves outcomes for these patients with limited treatment options.
  • A Phase 1/2 clinical trial of eprenetapopt with venetoclax and azacitidine for the frontline treatment of TP53 mutant AML met the primary efficacy endpoint of complete remission.

FDA Grants Breakthrough Therapy Designation for Venclexta in Combination With Azacitidine for the Treatment of Patients With Myelodysplastic Syndromes

Retrieved on: 
Wednesday, July 21, 2021
Research, FDA, Clinical trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Orphan drugs, Azacitidine, Lactams, Nucleosides, Triazines, Chemical substances, Chemistry, Myelodysplastic Syndromes (MDS), the M15-531 study, Venclexta, Genentech in Hematology, Genentech, MYELODYSPLASTIC SYNDROMES (MDS), THE M15-531 STUDY, VENCLEXTA, GENENTECH IN HEMATOLOGY, GENENTECH

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that Venclexta® (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the revised International Prognostic Scoring System (IPSS-R). MDS are a rare group of blood cancers that gradually affect the ability of the bone marrow to produce normal blood cells. This can lead to weakness, frequent infections, anemia and debilitating fatigue that can profoundly affect a person’s quality of life. In some cases, MDS can also progress into acute myeloid leukemia (AML). Every year in the United States, approximately 10,000 people are diagnosed with MDS, and the median survival for those with higher-risk MDS is approximately 18 months.

Key Points: 
  • We are pleased that the FDA has granted Venclexta its sixth Breakthrough Therapy Designation in recognition of its potential to improve outcomes for people with MDS in combination with azacitidine.
  • The patients doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta.
  • Patients should not receive a live vaccine before, during, or after treatment with Venclexta, until the patients doctor tells them it is okay.
  • The patients doctor will do blood tests to check their blood counts during treatment with Venclexta and may pause dosing.

Adial Announces Positive Pre-Clinical Data for its Adenosine Pain Platform

Retrieved on: 
Wednesday, July 14, 2021
Drugs, Psychoactive drugs, Analgesics, Purines, Adenosine, Nucleosides, Vasodilators, Pain management, Paracetamol, Ketamine

Dr. Robert D. Thompson, Adials Vice President, Chemistry, commented, We are highly encouraged by the latest preclinical data related to our adenosine platform as a potential therapy for pain relief.

Key Points: 
  • Dr. Robert D. Thompson, Adials Vice President, Chemistry, commented, We are highly encouraged by the latest preclinical data related to our adenosine platform as a potential therapy for pain relief.
  • Importantly, our latest solubility data may be the key to unlocking the potential of adenosine analogs as a therapy.
  • Also noteworthy, we studied our adenosine compounds in combination with Tylenol and demonstrated enhanced pain reduction and duration of pain relief in vivo.
  • Purnovate, Inc., a division of Adial Pharmaceuticals, is developing adenosine analogs for the treatment of pain and other disorders.

Bristol Myers Squibb Receives European Commission Approval for Onureg® (azacitidine tablets) as Frontline Oral Maintenance Therapy for Adults with Acute Myeloid Leukemia

Retrieved on: 
Friday, June 18, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Lactams, Nucleosides, Triazines, Azacitidine, Acute myeloid leukemia, 7+3, Leukemia, Chemical substances, Branches of biology, Cancer, Vadastuximab talirine, Acute eosinophilic leukemia

The approval of Onureg by the European Commission has the potential to clinically benefit and change the treatment paradigm of patients with acute myeloid leukemia, across a range of subtypes.

Key Points: 
  • The approval of Onureg by the European Commission has the potential to clinically benefit and change the treatment paradigm of patients with acute myeloid leukemia, across a range of subtypes.
  • The EC approval of Onureg was based on results from the QUAZAR AML-001 study, a Phase 3, international, randomized, double-blind trial.
  • Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission (QUAZAR AML-001).
  • New England Journal of Medicine 2020; 383:2526-2537; Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission.

Aprea Therapeutics Announces Phase 1/2 Trial of Eprenetapopt + Venetoclax + Azacitidine in TP53 Mutant AML Meets Complete Remission Primary Efficacy Endpoint

Retrieved on: 
Wednesday, June 16, 2021
Chemical compounds, Organic compounds, Branches of biology, Orphan drugs, Antineoplastic drugs, Lactams, Nucleosides, Triazines, Venetoclax, Azacitidine, P53

The trial met the primary efficacy endpoint of CR, which is based on a Simon 2-stage design.

Key Points: 
  • The trial met the primary efficacy endpoint of CR, which is based on a Simon 2-stage design.
  • As of the data cut, 11 patients remain on study treatment and continue to be followed for safety and efficacy.
  • We are pleased with these results from the combination of eprenetapopt with venetoclax and azacitidine in this very difficult-to-treat TP53 mutant AML population, a patient group with significant unmet medical need, said Eyal Attar, M.D., Chief Medical Officer of Aprea Therapeutics.
  • A pivotal Phase 3 clinical trial of eprenetapopt and azacitidine for frontline treatment of TP53 mutant MDS has been completed and failed to meet the primary statistical endpoint of complete remission.

ORYZON Presents Iadademstat ALICE 30-Month Data at EHA-2021, Confirming Positive and Robust Efficacy in Combination with Azacitidine in AML

Retrieved on: 
Friday, June 11, 2021
Lactams, Nucleosides, Triazines, Azacitidine, Chemical substances, Chemistry

The data were presented at the virtual EHA-2021 Conference, in an e-poster entitled ALICE MAINTAINS HIGH CLINICAL RESPONSE RATES SUPPORTING THE EFFICACY OF IADADEMSTAT COMBINATION WITH AZACITIDINE IN AML MANAGEMENT.

Key Points: 
  • The data were presented at the virtual EHA-2021 Conference, in an e-poster entitled ALICE MAINTAINS HIGH CLINICAL RESPONSE RATES SUPPORTING THE EFFICACY OF IADADEMSTAT COMBINATION WITH AZACITIDINE IN AML MANAGEMENT.
  • With historical response rates of 28% in this population when treated with azacitidine alone (19% CR/CRi and 9% PRs), these results support a strong synergy between iadademstat and azacitidine when used in combination.
  • The duration of the observed responses is also encouraging, with 60% of the CR/CRi lasting more than 6 months.
  • The combination of iadademstat with azacitidine continues to show a good safety profile with only two serious adverse events reported as probably related to treatment.

Phase 3 Clinical Trial Subgroup Analysis Across Solid Organ Transplant (SOT) Types Supports Efficacy of Maribavir Over Conventional Therapies in Post-Transplant Recipients With Cytomegalovirus (CMV) Infection (Refractory, With or Without Resistance)

Retrieved on: 
Monday, June 7, 2021
Science, Biotechnology, Research, Pharmaceutical, Surgery, Health, Infectious diseases, Clinical trials, Organic compounds, Chemistry, Chemical compounds, Benzimidazoles, Chloroarenes, Maribavir, Nucleosides, Human betaherpesvirus 5, Cytomegalovirus vaccine, CMV, Maribavir, Takeda’s SOLSTICE Trial, Takeda Pharmaceutical Company Limited, CMV, MARIBAVIR, TAKEDA’S SOLSTICE TRIAL, TAKEDA PHARMACEUTICAL COMPANY LIMITED

Most recently, the FDA has granted priority review of maribavir for the treatment of post-transplant recipients with CMV infection in those R/R to prior anti-CMV treatment.

Key Points: 
  • Most recently, the FDA has granted priority review of maribavir for the treatment of post-transplant recipients with CMV infection in those R/R to prior anti-CMV treatment.
  • Avery R. Randomized Phase 3 Open-Label Study of Maribavir vs Investigator-Assigned Therapy for Refractory/Resistant Cytomegalovirus Infection in Transplant Recipients: Subgroup Analyses of Efficacy by Organ.
  • Duarte R. Maribavir Versus Investigator-Assigned Therapy for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus Infection: Efficacy Data From a Randomized Phase 3 Open-Label Study.
  • Clinical impact of neutropenia related with the preemptive therapy of CMV infection in solid organ transplant recipients.

Global Adenosine Triphosphate Swab Test Market Forecast to 2027 - COVID-19 Impact and Analysis - ResearchAndMarkets.com

Retrieved on: 
Monday, May 31, 2021
Health, Pharmaceutical, Medical specialties, Adenosine, Nucleosides, Purines, Vasodilators, ATP, Clinical medicine, Drugs

The "Adenosine Triphosphate Swab Test Market Forecast to 2027 - COVID-19 Impact and Global Analysis By Type and Application" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Adenosine Triphosphate Swab Test Market Forecast to 2027 - COVID-19 Impact and Global Analysis By Type and Application" report has been added to ResearchAndMarkets.com's offering.
  • The adenosine triphosphate (ATP) swab test market was valued at US$ 198.21 million in 2019 and is projected to reach US$ 369.71 million by 2027; it is expected to grow at a CAGR of 8.10% from 2019 to 2027.
  • The implementation of safety measures to prevent the spread of COVID-19 is driving the adoption of adenosine triphosphate (ATP) swabs.
  • Moreover, the major shift in focus toward microbial safety amid the pandemic is offering lucrative opportunities for the growth of the market players.

Can-Fite BioPharma Interview to Air on Bloomberg Television U.S. on the RedChip Money Report®

Retrieved on: 
Thursday, May 27, 2021
Biotechnology, Pharmaceutical, Publishing, Oncology, Health, TV and Radio, Communications, Entertainment, Purines, Medical specialties, Adenosine, Nucleosides, Vasodilators, Binding selectivity, Clinical medicine, Drugs, Piclidenoson, Namodenoson, Can-Fite BioPharma Ltd., PICLIDENOSON, NAMODENOSON, CAN-FITE BIOPHARMA LTD.

In the exclusive interview, Dr. Fishman discusses the Companys upcoming milestones, updates on the pipeline of proprietary small molecule drugs addressing inflammatory, cancer and liver diseases.

Key Points: 
  • In the exclusive interview, Dr. Fishman discusses the Companys upcoming milestones, updates on the pipeline of proprietary small molecule drugs addressing inflammatory, cancer and liver diseases.
  • To view the interview segment, please visit: https://youtu.be/WVxnEwJ8WXo
    The RedChip Money Report" delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies.
  • Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR).
  • Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

Forma Therapeutics to Present Data from Pivotal Phase 2 Trial of Olutasidenib at ASCO 2021

Retrieved on: 
Thursday, May 20, 2021
Research, Clinical trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Oncology, Lactams, Orphan drugs, Nucleosides, Triazines, Azacitidine, 7+3, Chemical substances, Health, Clinical medicine, the Phase 1/2 Study, Olutasidenib, Forma Therapeutics, THE PHASE 1/2 STUDY, OLUTASIDENIB, FORMA THERAPEUTICS

The data indicate the duration of CR/CRh for people on treatment was 13.8 months.

Key Points: 
  • The data indicate the duration of CR/CRh for people on treatment was 13.8 months.
  • \xe2\x80\x9cThe safety data from the treatment cohort are consistent with the findings from our Phase 1 evaluation in this high-risk AML patient population.
  • Phase 1 of the trial, 2102-HEM-101, was an open-label, dose-escalation and expansion study of olutasidenib alone and in combination with azacitidine (AZA).
  • The Phase 2 portion was an open-label, fixed-dose study of olutasidenib as a monotherapy and in combination with AZA in multiple IDH1m AML/MDS populations.